(300 days)
No
The description focuses on data reception, storage, management, and display, acting as a communication hub without modifying data. There are no mentions of AI, ML, or related concepts, and the performance studies are focused on software development lifecycle and risk management, not algorithmic performance metrics.
No
The device is described as software that receives, stores, manages, and displays patient physiological and waveform data and alarms. It acts as a communications hub and remote viewing software for patient monitoring. It does not exert any therapeutic effect on the patient.
No
The device collects, stores, manages, and displays patient physiological and waveform data and alarms, acting as a communication hub and remote viewing software. It does not perform analysis or interpretation of data to arrive at a diagnosis.
Yes
The device description explicitly states it is "software" and "runs on commercial IT equipment," acting as a communications hub and remote viewing software without mentioning any proprietary hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "centralized monitoring of patient data within a healthcare facility" and receiving, storing, managing, and displaying "patient physiological and waveform data and alarms." This describes a system for monitoring vital signs and other patient data, not for performing tests on biological samples.
- Device Description: The description focuses on the software's function as a "communications hub" and "remote viewing software" for patient monitoring data. It doesn't mention any interaction with biological samples or reagents.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Use of reagents
- Diagnosis or screening based on laboratory test results
The device is clearly designed for patient monitoring and data management within a clinical setting, which falls under the category of patient monitoring systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
Product codes
DXJ
Device Description
The Vios CS SW enables the Vios Monitoring System to be used in networked mode within a healthcare IT network and runs on commercial IT equipment.
The Vios CS SW operates as a communications hub that can pass the data generated by Vios proprietary vitals monitoring software to one or more remote viewing software applications, without modifying the data.
The Vios CSM SW is the remote viewing software of the Model 2050 system. It allows up to 16 devices to be displayed on one screen and runs on a commercial IT device that satisfies defined Vios-defined technical specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance of the Vios CSM/CS SW Model 2050 has been evaluated through non-clinical testing and analysis:
System and Subsystem Software Development Life Cycle (62304)
System and Subsystem Design Verification and Validation Testing
System and Subsystem Risk Management (14971)
Key Metrics
Not Found
Predicate Device(s)
GE Healthcare CARESCAPE Central Station v2 (reference K162012)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2018
Vios Medical, Inc. Megan Graham Quality Regulatory Adviser 7300 Hudson Blvd N St. Paul, Minnesota 55128
Re: K173107
Trade/Device Name: Vios Central Station Monitor/Vios Central Server Software 2050 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: September 28, 2017 Received: September 29, 2017
Dear Megan Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Megan Graham
1000-1050.
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Arielle Drummond -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173107
Device Name
Vios Central Station Monitor/Central Server Software Model 2050
Indications for Use (Describe)
The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Vios Medical, Inc.
7300 Hudson Rd Blvd N
Suite 140
St. Paul, MN 55128 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Megan Graham
Quality and Regulatory Advisor
megan@viosmedical.com
Office: 651-764-8467
Fax: 651-237-7003 |
| Date Prepared: | September 28, 2017 |
| Trade Name: | Vios Central Station Monitor/Central Server Software Model 2050 |
| Common Name: | Central monitoring software |
| Regulation: | 21 CFR Part 870.2450 Medical cathode-ray tube display |
| Classification: | Class II |
| Review Panels: | Cardiovascular |
| Product Codes: | DXJ |
| Predicate Device: | GE Healthcare CARESCAPE Central Station v2 (reference K162012) |
| Device Description: | The Vios CS SW enables the Vios Monitoring System to be used in networked
mode within a healthcare IT network and runs on commercial IT equipment. |
| | The Vios CS SW operates as a communications hub that can pass the data
generated by Vios proprietary vitals monitoring software to one or more
remote viewing software applications, without modifying the data. |
| | The Vios CSM SW is the remote viewing software of the Model 2050 system.
It allows up to 16 devices to be displayed on one screen and runs on a
commercial IT device that satisfies defined Vios-defined technical
specifications. |
| Indications for Use: | The Vios CSM/CS Software is indicated for use by healthcare professionals
for the purpose of centralized monitoring of patient data within a healthcare
facility. The Vios CSM/CS SW receives, stores, manages, and displays patient
physiological and waveform data and alarms generated by Vios proprietary
patient vitals monitoring software. |
| Summary of
Substantial
Equivalence: | The Vios CSM/CS SW Model 2050 is substantially equivalent to the predicate
device with respect to central station monitoring in a healthcare facility
(product code DXJ). Both the Vios CSM/CS SW Model 2050 and its
predicates meet the same standards of safety and efficacy. Risk analysis of
Vios CSM/CS SW Model 2050 demonstrates that no additional risks are
introduced. Additional functionality of the predicates is outside the scope of
the Vios CSM/CS SW Model 2050. |
| Non-Clinical
Testing: | The performance of the Vios CSM/CS SW Model 2050 has been evaluated
through non-clinical testing and analysis: |
| | System and Subsystem Software Development Life Cycle (62304) System and Subsystem Design Verification and Validation Testing System and Subsystem Risk Management (14971) |
| Conclusion: | Vios Medical considers the Vios CSM/CS Software Model 2050 to
substantially equivalent to the legally marketed predicate device. |
K173107
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